Art in Improving Outcomes in Participants Undergo Surgery

NCT03688945 | Terminated

• 2 other identifiers: I 43217NCI-2018-00457
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This trial studies how well art works in improving outcomes in participants who are undergoing surgery. Exposure to art may help to improve clinical and psychological outcomes.

Conditions

Health Status Unknown

Outcome Measures

Primary Outcomes (1)

• Mental health wellbeing score

  Will be assessed by using a Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS). This is a 14 item scale with 5 response categories that cover both feeling and functioning aspects of mental wellbeing.

  Up to 2 years

Secondary Outcomes (5)

• Reduced pain: NRS

  Up to 2 years

• Anxiety score (patient)

  Up to 2 years

• Hope score

  Up to 2 years

• Change in blood pressure

  Up to 2 years

• change in recovery of bowel function

  Up to 2 years

Study Arms (2)

Arm I (art sessions)

EXPERIMENTAL

Participants attend at least 1 session of viewing art pieces over 15 minutes every day for 2 years.

Procedure: Art Therapy; Other: Questionnaire Administration

Arm II (standard of care)

ACTIVE COMPARATOR

Participants receive standard of care for 2 years.

Other: Best Practice; Other: Questionnaire Administration

Interventions

Art Therapy PROCEDURE

Attend art viewing sessions

Arm I (art sessions)

Best Practice OTHER

Receive standard of care

Also known as: standard of care, standard therapy

Arm II (standard of care)

Questionnaire Administration OTHER

Ancillary studies

Arm I (art sessions); Arm II (standard of care)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Ambulant inpatients that will stay for at least 2 days postoperatively and do not require continuous monitoring
• All races and ethnic groups are eligible for this study

You may not qualify if:

• Patients with altered mental status, psychiatric illness, debilitating pain, blind patients, or those who require continuous monitoring postoperatively will be excluded from the study
• Adult unable to consent, individuals who are not yet adults, pregnant women or prisoners

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Interventions

Art Therapy; Practice Guidelines as Topic; Standard of Care

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities; Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Study Officials

• Khurshid Guru

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2018
• First Posted: September 28, 2018
• Study Start: August 7, 2017
• Primary Completion: November 27, 2019
• Study Completion: November 27, 2019
• Last Updated: July 25, 2022

Record last verified: 2022-07

Locations

US (1)